Tadalafil oral suspension

JP2024541013A5Pending Publication Date: 2025-11-04FARMALIDER
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Patent Information

Application Number
JP2024524693
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-10-25
Filing Date
2022-10-24
Publication Date
2025-11-04

AI Technical Summary

Technical Problem

Existing tadalafil formulations, particularly liquid suspensions, face challenges in achieving chemical and physical stability, sedimentation issues, and do not provide an in vitro dissolution profile equivalent to commercial solid formulations like Cialis® film-coated tablets, making them unsuitable for patients with swallowing difficulties and requiring alternative dosage forms.

Method used

A tadalafil pharmaceutical composition in the form of an aqueous oral suspension, comprising tadalafil, cyclodextrin, co-processed MCC-NaCMC, and xanthan gum, which ensures chemical and physical stability and an in vitro dissolution profile similar to Cialis® tablets, allowing for fixed-dose combinations with drugs like tamsulosin or dutasteride.

Benefits of technology

The composition provides a stable and effective oral suspension with a dissolution profile comparable to Cialis® tablets, facilitating easy administration and tailored dosages, enhancing therapeutic efficacy for conditions like erectile dysfunction and benign prostatic hyperplasia.

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Abstract

The present invention relates to a tadalafil oral suspension comprising 0.01-5% (w / v), cyclodextrin, co-processed crystalline cellulose and sodium carboxymethylcellulose, xanthan gum and water as a vehicle. The suspension is chemically and physically stable and exhibits a dissolution profile equivalent to that of commercially available tadalafil film-coated tablets. The tadalafil suspension is suitable for the treatment of male erectile dysfunction and prostatic hyperplasia. The present invention also relates to a fixed dose combination dosage form comprising the tadalafil and either tamsulosin, particularly in the form of a modified release tablet, or dutasteride. The combination dosage form is useful for the treatment of lower urinary tract symptoms associated with prostatic hyperplasia. The present invention also relates to a method for the preparation of the tadalafil composition.
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